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CN103861163B - The modularization hemofiltration equipment of have interactive operation person's instruction and control system - Google Patents

The modularization hemofiltration equipment of have interactive operation person's instruction and control system Download PDF

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Publication number
CN103861163B
CN103861163B CN201410068996.XA CN201410068996A CN103861163B CN 103861163 B CN103861163 B CN 103861163B CN 201410068996 A CN201410068996 A CN 201410068996A CN 103861163 B CN103861163 B CN 103861163B
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China
Prior art keywords
panel
blood
fluid
operator
filter core
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Application number
CN201410068996.XA
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Chinese (zh)
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CN103861163A (en
Inventor
哈罗尔德·彼得斯
亚当·海恩泽尔曼
雅各布·凯尔恩斯
汤米·库珀
迈克尔·戴尔梅至
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B Braun Avitum AG
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B Braun Avitum AG
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424Substitution fluid path
    • A61M1/3431Substitution fluid path upstream of the filter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424Substitution fluid path
    • A61M1/3431Substitution fluid path upstream of the filter
    • A61M1/3434Substitution fluid path upstream of the filter with pre-dilution and post-dilution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424Substitution fluid path
    • A61M1/3437Substitution fluid path downstream of the filter, e.g. post-dilution with filtrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3401Cassettes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3622Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362263Details of incorporated filters
    • A61M1/362264Details of incorporated filters the filter being a blood filter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/125General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/128General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • A61M2205/505Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6018General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Person's control system that the equipment that substitutes patient treatment for carrying out the fluid management of selection and/or kidney is characterised in that interactive operation, this interactive operation person control system has operator's input optionally to change panel kit, replace filter core and/or change to different patient treatment methods during the current patient treatment carrying out, and this interactive operation person control system has been provided for operator's instruction of the task of foregoing. In one embodiment, the feature of interactive operation person control system is also, during system setting, automatically and sequentially identify pending different setting steps, substantially in whole system setting up procedure, show step in succession and in different setting steps each in the pending task in succession of operator interface therewith screen display.

Description

The modularization hemofiltration equipment of have interactive operation person's instruction and control system
Background technology
Hemodialysis system is designed to carry out haemodialysis program, as slow continuity ultrafiltration(SCUF), during continuous venovenous hemofiltration (CVVH), continuous venovenous bloodLiquid dialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF). ThisThe continuous renal replacementtherapy that is called as a bit CRRT be designed to metabolic waste andExtra body fluid is from superfluous in body fluid and need to remove the patient of kidney support. At present canThe extracorporeal blood treatment equipment obtaining needs inconvenient and setting program consuming time, these journeys conventionallyOrder comprises for different patients with for transducer potector and/or the fluid hose of different treatment methodsRoad is cleaned and/or is changed. These programs need to move to equipment from patient's bed side or roomAnother location, or by equipment replace be set up and be configured to carry out concrete methods for the treatment of beSystem.
The 5th, 910, No. 252 United States Patent (USP)s have been described to be configured for and have been carried out different haemodialysisThe equipment of method and the device for selecting one of pending methods for the treatment of is provided. Institute retouchesThe equipment of stating is following whole assembly: must for any institute of haemodialysis method of selectingThe pump of palpus, pipeline, the supply of multiple fluid reservoir, waste fluid container and filter core.
The 6th, 200, No. 485 United States Patent (USP) has been described another multipurpose blood filtering system, its bagDraw together: the assembly of blood filter core, pump, fluid reservoirs and waste fluid container; Be used for contrasting streamThe parts of the weight of body reservoir and waste fluid container; And for during treating in response to rightThe device that the weight of ratio is controlled pump operated and speed.
The Prismaflex being released by treasure (Gambro) company of Lakewood (Lakewood)TMSystem provides the selection to different CRRT methods of treatments. This system allows user to selectAssembly packing in advance, assembling in advance is to carry out the methods for the treatment of of selecting, and this assembly will compriseAll parts of the type of the surface area of concrete post and filter membrane or molecular filter and for carry outAll pipeline combinations that connect in advance of the methods for the treatment of of selecting.
Be the 12/183rd of submission on July 31st, 2008, No. 537 U.S. Patent applications(TRANSVl.024A) modularization blood filter equipment has been described in, its have for multiple andThe removable panel of haemodialysis method alternately. Equipment described in above-mentioned application and beSystem provides treatment system flexibly, the system is characterized in that a kind of panel assembly, this panelAssembly has and is arranged on dismountable on apparatus casing control module and can abandons panel, therefore peacePanel-mounted filter post and/or pipeline group are replaceable for having the mistake of different pipeline configurationsFilter and/or panel are to adapt to different blood treatment methods of treatments. The full content of above-mentioned applicationBe incorporated to by reference herein.
Be the 61/105th of submission on October 15th, 2008, No. 703 interim patent of U.S. ShensPlease, in (TRANSVI.025PR), the above-mentioned modularization blood with removable panel is also describedLiquid filters equipment, and this equipment comprises special and unique panel designs and pipeline configuration. BeThe 61/105th of submission on October 15th, 2008, No. 712 U.S. Provisional Patent Application(TRANSVI.026PR) in, disclose such parts and feature, it is for passing through operationEasily and effectively manual installation and remove panel and filter core of person. In above-mentioned provisional application wholeHold and be incorporated to by reference respectively herein.
Summary of the invention
Equipment described herein comprises: control module, has blood pump and fluid pump; Manually peaceThe capable replacing faceplate external member of dress, is arranged on control module, has blood and fluid on panelSupply line; Replaceable filter core; Controller CPU, is configured to operation and comprises blood pump and fluidPump is in interior system; And interactive operation person control system, have with controller operability and connectThe operator interface therewith screen connecing. Controller CPU comprises one or more micro-processing with softwareDevice, this software is configured to carry out operating equipment and provide to equipment in response to operator's input selectionThe state of operational order and selected treatment parameter. The feature of interactive operation person control system existsIn, operate defeated inflow and select CRRT patient treatment method, change panel kit, replace filterCore and from the current methods for the treatment of of carrying out of patient change to different patient treatment methods and withoutChange panel or filter core. Operator's input control panel also provides step-by-step operation person's instruction to changePanel kit, replace filter core and change patient treatment method during carrying out patient treatment. Hand overFormula user control system adopts the operator interface therewith touch-screen with image control mutually, thus behaviourAuthor can selective system operate, and interactive user's control system is provided with instruction to carry outThe operation of selected system and patient treatment stage. This system also provides in current institute to operatorIn the treatment stage of selecting, patient is temporarily disconnected and start-up routine afterwards, and forCarry out detailed operator's instruction of these programs. In another embodiment, operator controls systemSystem be characterised in that setting program, this setting program be included in system and arrange during automatically and suitableThe different setting steps of order ground mark show setting steps substantially in whole system setting up procedure,And for the current setting steps of carrying out, operator interface therewith screen display is shown and is treated to be held by operatorThe subsequent task of row. By following detailed description, these of equipment and use thereof and miscellaneous part,Characteristic, parameter and advantage will be more apparent.
Brief description of the drawings
Fig. 1 and 2 is the stereogram of blood filtering control appliance, wherein shows and is arranged on controlThe front side of the panel assembly in unit housings and not homonymy;
Fig. 3 is the schematic diagram of modularization haemodialysis equipment, wherein shows inner panel fluidWith transducer potector layout designs, and 3 fluid storage bags are communicated with pipeline fluid;
Fig. 4 shows inner panel surface, and it has the blood supply of being arranged on and fluid supplyThe blood filter filter core of the pipeline in the center panel of panel and connection and installation;
Fig. 5 and 6 schematically shows and is configured to carry out selected CRRT blood filtrationThe parts of the equipment of methods for the treatment of;
Fig. 7 and 8 schematically shows for carrying out plasma separation and plasma treatment embodimentThe parts of equipment;
Fig. 9 A and 9B illustrate the operator interface therewith screen of some steps for changing panel kitText message instruction;
Figure 10 A and 10B diagram are used for operator's instruction of some steps of replacing filter core;
Figure 11 illustrates for making patient temporarily disconnect reboot process afterwards during treatingOperator's instruction screen;
Figure 12 shows the operator's instruction for changing bag;
Figure 13 A-13F and Figure 15 A-15C illustrate multiple setting operation person interface screen and in successionSetting steps; And
Figure 14 A-14C illustrates fluid and flows and alarm adjustment screen.
Detailed description of the invention
Fig. 1 and 2 illustrates the side view of the relative both sides that obtain from the anterior angle of equipment, wherein showsGone out to comprise the blood filtering assembly of control module housing 10, this control module housing 10 hasOperator interface therewith touch-screen 11. Figure 1 illustrates blood side, and by blood panel 12In opening can be observed blood pump rotor 14. In Fig. 2, by the sight in fluid panel 20Examine mouth and can see 3 fluid pump rotors 17,18,19. Show in front portion blood filter is installedThe filter core panel 16 of device 25. Detachable blood filter is fastened on front panel by filter core band 27,Filter core band 27 is through the slotted eye in front panel. Filter core band can be provided with contact-type, adjustable easilySecure component is as hook circle hasp (Velcro) parts, it is easy to size differenceFilter core carry out fastening. Alternatively, the contact surface of blood filter and front panel can be provided with and contactAttachment arrangement. The panel of panel assembly group passes through feature and the portion of further explaining hereinafterPart is arranged on control module housing. Figure 1 illustrates air detectors 15 and reflux pipelinePincers 13 also show fluid storage bag 21,22,23 in Fig. 1 and 2.
The inside of three panel groups has been shown in Fig. 3 and 4, and on wainscot surface or contiguousWainscot surface is provided with pipeline, and shows in order to engage and to establish with each blood pump and fluid pumpThe relation of the pipeline of putting. Also show the connection each other of the part of pipeline or sections, with filterThe connection of core, fluid pressure sensor, fluid supply container and dirt pocket and with for guidingThe sleeve pipe that blood flow flows out to patient or from patient or the connection of conduit.
Blood panel 12 comprises along the blood inside of panel, that install on general planar surfaceSupply line. In the time that blood panel is fixedly mounted on control module housing, blood supply tubeU-shaped bending part 49 arch on road, upwards bending engages with blood pump rotor 14. At bloodPanel is provided with 3 pressure sensors 41,42,43, blood supply pipe passage differentPart is through these 3 pressure sensors 41,42,43. The end of blood inflow line 30 is attachedBe connected to patient and approach device as needle-like sleeve pipe or conduit tube component 52, and comprise for turn-offing bloodThe pincers of supply line. Blood pump 14(Fig. 1, Fig. 3) blood by blood along blood supply pipelineLiquid inflow line 30 is also pumped to filter core 25 via blood inflow adapter 29 from patient. Pass through bloodThe fastening blood backflow pipeline 32 of opposed end of liquid backflow adapter 31 and filter core comprises guidingBlood backflow pipeline is by pressure sensor 42 and arrive needle-like thimble assembly and/or conduit 53Sections. Each of pressure sensor has the pressure signal electricity that is attached to sensor plug 45Cable, sensor plug 45 is waited to be inserted in the socket on control module housing and for rightEnter from each pressure sensor and along the pressure signal that blood flows into and blood backflow sections transmitsRow monitoring.
The fluid side of assembly comprises fluid panel 20, and this fluid panel 20 has along substantiallyThe pipeline that the inner surface of plane is installed. Fluid circuit is configured and is shaped to and is fastened to control3 fluid pumps 17,18,19 of unit engage. Similar with the configuration of blood supply pipeline, 3Individual arch or U-shaped pipeline sections 46,47,48 are configured to connect with the rotor of corresponding fluids pumpClose, pass through pipeline to order about fluid. The fluid pump of different pipeline sections and cooperation will be from mistakeThe dislysate of filter, displacement liquid, saline solution/anti-freezing liquid (depending on the configuration of equipment and haemodialysis)And soiling solution or waste liquid guide to waste rexeptacle or litter bag. More specifically, displacement fluid pipeline38 guide to blood by the displacement fluid from displacement fluid bag 21 via arch pipeline sections 46Inflow line 30 also enters the upper end of filter core 25. Second fluid Pipeline 34 will be from thoroughlyThe dislysate of analysing fluid pouch 23 guides to the sidepiece of filter core 25 via arch pipeline sections 47. TheThree fluid circuit sections guide to waste liquid by the dirt from filter core via arch pipeline sections 48Collecting bag 22. On fluid panel, be also provided with pressure sensor 44. In a preferred embodiment,All pressure sensors are all arranged on separately on panel, thereby are fixedly mounted in control when panelIn unit housings time, pressure sensor, all in same vertical height, reads pressure accuratelyNumber can be obtained and compare without further adjustment in the situation that, and in other cases, canCan need this further adjustment to compensate with the difference to sensor height. Above-mentioned12/183, No. 527 U.S. Patent application (TRANSVI.024A) and the 61/105th, No. 703 U.S.sIn state's provisional application (TRANSVI.025PR), describe and show pipeline at corresponding bloodOn panel and fluid panel layout more specifically with detailed description.
Engage and tension clips by the panel that is attached to case frame, by three panel kits manuallyBe arranged on control module housing. Observe Fig. 1 and 2, be positioned at a side of control module housingErecting of panel folder 56 is biased by the spring to extend through the slotted eye 62 on blood panel, positionBe biased by the spring with through in stream in the erecting of panel folder 58 of the opposite side of control module housingSlotted eye 64 on dignity plate extends, and (referring to Fig. 1,2,4) aimed in these holes with mounting clamp.Mounting clamp is shaped to provide the inclined flange of extending by bore portion, and this flange overcomes mounting clampSpring biasing urges the edge in hole, thereby spring is loaded. These mounting clamps are from engagement typeAnd when flange engages during by hole in place. In order to remove side panel, operator is manually to sideFace urges each spring loading clamp until it is in place and can pass hole. Front panel 16 and two are prominentGo out pin or hook 55,57 alignings, each protrudent pin or hook have the button of expansion at its end(button) shape portion or flange and comprise less bar. Hole on front panel is shaped asThere is the aperture of expansion and narrow slotted eye. In the time that front panel is installed, operator is by aperture and expansionPin aim at, make panel press housing and extend to make pin pass aperture, and it is less that bar is placed inSlotted eye in. Afterwards, operator engages blood panel and fluid panel by above-mentioned mounting clampIn installation site, mounting clamp engages with panel in the position of hope. Thereby panel can be easily alsoEffectively by manual installation and be disengaged to remove. Be to submit on October 15th, 2008The 61/105th, in No. 712 U.S. Provisional Applications (TRANSVI.026PR) to installing component andProcess has been done to further describe, and the full content of its description is incorporated to herein by reference.
Also, with reference to Fig. 5 and 6, wherein show the schematic part of equipment, these parts are joinedBe set to and carry out the selection CRRT haemodialysis journey recorded in " background technology " part first paragraphOrder. Figure 5 illustrates the configuration of equipment, it is for carrying out CVVH with by fluid motion(convection) remove solute and carry out removing fluids by ultrafiltration. The film of blood filter is by superFilter separates blood plasma water, and is pumped into blood from the displacement liquid of container 21 by pump 17In flow path. In displacement liquid, be added on by the fluid selection solute running off that flows. When enteringWhen row treatment, the concentration of unwanted solute reduces, and required solute is to maintain proper levelConcentration replaced. The solute removing is directed to litter bag 22 by sewage pump 19. Fig. 5Shown in equipment can be for carrying out SCUF, only to remove extra patient by ultrafiltrationFluid. For SCUF, do not use any displacement liquid or dislysate, replace by removalLiquid bag 21 to shown in equipment modify, and pump 17 is not operated.
The configuration of the equipment of Fig. 6 can be for carrying out CVVHD and CVVHDF. CVVHDRemove solute and remove patient's fluid by ultrafiltration by diffusion. For CVVHD, do not introduce any displacement liquid, can remove displacement liquid bag 21, and pump 17 not enteredLine operate. But the two uses dialysate fluid, dislysate CVVHD and CVVHDFFluid is directed in blood filter 25, and unwanted solute is crossed in filter from blood flowFilm by diffusing in dialysate fluid. For CVVHDF, displacement fluid is from puttingChange liquid bag 21 and be pumped to blood flow pipeline. As shown in the figure, can incite somebody to action in the upstream of filterDisplacement liquid is added in blood flow, or in the downstream of blood filter 25, displacement liquid is introduced to patient and returnIn stream pipeline.
Carrying out, in above-mentioned treatment, can adding anti-coagulants to displacement fluid, as heparin, lemonAcid element or other anti-coagulants, or can establish by using syringe, pump or other fluids to injectThe blood that anti-coagulants introducing is derived from patient by the standby upstream at blood filter enters pipeline. Equally canThe parts (not shown) that uses suitable fluid injection device to patient to be back to through filteringBlood in add blood plasma and/or albumen.
System described herein and equipment can be configured to not only carry out replace for continuous kidneyContinuous fluid management and 4 kinds of kidney replacement therapy methods of generation treatment, also for by blood plasma from bloodIn liquid, separate, process blood plasma to remove toxin and additional fluid and being used for the treatment of property plasma exchange,Below will further be described this. Equipment shown in Fig. 7 and 8 illustrates for carrying outPlasma separation, plasmapheresis, plasma exchange, liver support and therapeutic plasma displacementThe configuration of system. Shown in configuration in, the blood shown in plasma separator 40 alternate figures 5 and 6Filter 25. Blood plasma separates from blood samples of patients, is abandoned afterwards and replaces, or blood plasma is enteredRow processes that the disease association composition of selecting or other poisonous substances, toxin, medicine etc. are separatedWith remove and/or neutralize. In Fig. 7, shown in system be configured to carry out plasma exchange. FromPatient's blood is pumped to plasma separator cylinder (cartridge) 40, plasma separator cylinder 40The blood plasma of the film through plasma separator cylinder is separated. Separated blood plasma is by pump 19Be pumped to blood plasma litter bag 22, from the displacement blood plasma of plasma infusion bag 26 by pump 18 pumpings.Also show anti-coagulants and salt liquid pump. Can be at plasma separation cylinder place or at its upstream will be from bag24 anti-coagulants and/or saline solution are added into blood.
Fig. 8 illustrates for the treatment of separated blood plasma to carry out the equipment of selective plasma treatmentEmbodiment. This selective plasma treatment is called as therapeutic plasma displacement, and comprises thisThe equipment of sample, this equipment can optionally remove disease association composition, as toxin, antibody,Protein, pathogen including bacterium, virus etc., and can remove or neutralizating medicineThe chemical substance of thing, poisonous substance or other selections. As shown in Figure 8, be selection by blood plasma pump 19Property plasma treatment equipment or therapeutic plasma replacing apparatus 50 provide separated blood plasma with to thisBlood plasma is processed. Plasma treatment equipment can comprise that plasma exchange parts, centrifugal or film divideFrom formula filter, cascade or multiple filtration membrane and post (column), can absorb concrete diseaseOne or more absorbing barrels and the activated carbon cylinder of sick Related Component or medicine. Selective compositionOther examples of removing device comprise: dedicated columns, is combined with synthetic as crosslinked polyvinyl alcoholGel beads or many microporous fibres element pearl, to remove concrete amino acid ligand and antibody; And processParts, can chemically process blood plasma so that heparin, saliferous amino acid (salt-aminoacid)Precipitation, or effectively neutralize for the medicine to blood plasma, poisonous substance or disease association composition.This equipment also can be for liver support function. In addition, selective plasma treatment equipment can be byDifferent the plasma treatment unit Series that uses or combination in parallel, side by side or concomitantly to carry outMultiple plasma treatment or treatment. Treated blood plasma is by being connected with blood samples of patients reflux pipeline 32Pipeline 33 be directed to patient. If needed, equipment can be configured to have 4 fluidsPump, to deliver to patient's reflux pipeline or waste rexeptacle by treated blood plasma pump. Show supplementaryFluid pump 18, its for future self-selectively plasma treatment equipment 50 waste liquid guide to uselessThing bag 51. The 6th, in 849, No. 183 United States Patent (USP)s and control at TherapeuticApheresis(Treat property plasma exchange), Vol.1, No.2, May1997, in pages135-146 to selective one-tenthDivide removing device and technology to carry out additional description, wherein the relative section of United States Patent (USP) is by drawingWith being incorporated to herein. The 5th, these cylinder or plasma exchange portions are disclosed in 605, No. 627 United States Patent (USP)sOther examples of part, filter etc., the relevant portion of this United States Patent (USP) is incorporated to herein by reference.Selective plasma treatment equipment can be designed to allow operator when needed to filter, post,The configuration of cylinder etc. exchanges, changes, has revised the different plasma treatment to patient.
One of the embodiment of equipment described herein and system is characterised in that interactive operationPerson's controlling feature. This feature can comprise operator interface therewith, and this operator interface therewith provides equipment operatingInstruction and therapeutic state and parameter. In following described embodiment, this interface is tactileTouch screen interface. But, also can consider other well-known interfaces, as used conventional buttonOr those interfaces of switch.
For example, the input unit that used here can be keyboard, spin, mouse, voice knowledgeOther system maybe can be sent to information other devices of computer from user. Input unit alsoCan be the touch-screen being associated with display, in this case, user touches by touching thisTouching screen responds the prompting on display. User can be by input unit as keyboard orTouch-screen carrys out inputting word information.
Here the instruction that used refers to the computer for the information of system is processedThe step of carrying out. Instruction can be carried out and comprise by system in software, firmware or hardwareThe programming step of any type that parts carry out.
Local Area Network or wide area network (WAN) can be the enterprises that comprises internet accessOperational network, computer is connected with this enterprise's operational network with the calculation element that comprises this system. ?In an embodiment, LAN meets transmission control protocol/Internet protocol (TCP/IP) industryStandard.
Here the medium that used refer to image in the system of being imported into, sound, video orThe data of any other multimedia type.
Microprocessor can be any traditional general purpose single-chip or multi-chip microprocessor, as runs quicklyRiseProcessor, Pentium ProProcessor, 8051Processor, million instructions per secondProcessor, powerProcessor or AlphaProcessor. In addition, microprocessor can be any biographyThe special microprocessor of system, as digital signal processor or graphic process unit. Microprocessor is commonThere is traditional address wire, traditional data wire and one or more traditional control line.
System is by the various module compositions that discuss in detail below. One of those skilled in the art canUnderstand, each module comprises each seed routine, program, definition statement and macros. Each mouldPiece is conventionally compiled separately and is linked with single executable program. Therefore, adopt often belowIndividual module is described so that describe the functional of optimum decision system. Thereby entered by each moduleThe program of row can be at random re-assigned to one of other modules, in individual module, be tiedBe combined or for example can be obtained in sharing DLL.
System can be with various operating system as LINUX, UNIX or MICROSOFTUse combines.
System can by any traditional programming language as C, C++, BASIC, Pascal,Or Java writes, and move under traditional operating system. C, C++, BASIC,Pascal, Java or FORTRAN are professional standard programming languages, therefore can use manyBusiness compilation tool produces executable code.
Invention disclosed herein may be implemented as the article of method, equipment or manufacture, its useStandard program or engineering are to produce software, firmware, hardware or their any combination. ThisThe term " article of manufacture " that literary composition uses refers at hardware or computer-readable medium as opticsThe code of carrying out in memory device and volatibility or non-volatile memory device or logic. ThisHardware can include but not limited to field programmable gate array (FPGA), special IC(ASIC), CPLD (CPLD), programmable logic array (PLA),Microprocessor or other similar treating apparatus.
Operator's control system allows operator carry out the selection of patient treatment method and ought advanceDuring the treatment of row, change patient treatment method. The feature of interactive operation person control system also existsIn provide operator's instruction progressively optionally changing fluid pouch, replace panel kit, moreRenew cartridge, the temporarily treatment that patient disconnected and restart afterwards, above whole placesIn the patient treatment phase process of current operation or operation. The control module of equipment comprises with softThe controller of part link, this controller is configured to by the literary composition in operator interface therewith screen displayThis or image message provide aforesaid operations instruction. On the processor of interface module in equipment, transportGo and be to scan from the user input of touch-screen. If interface module detects usePerson input, this interface module operation finger corresponding with the indicator having activated on touch-screenOrder.
Fig. 9 A to Figure 12 illustrates the different screen of indicating pending step to operator, theseStep be performed with during the treatment of current operation, change bag, panel kit, replacement filter,Make patient disconnect, leave treatment or change treatment. Then touch by pressing operation screen buttonPress label to visit the instruction of hope.
With reference to Fig. 9 A and Fig. 9 B, wherein show the example of continuous operator interface screen,It illustrates the instruction that changes panel kit to operator. Screen shown in Fig. 9 A comprises " moreChange external member (ChangeKit) " indicator button, operator can press or trigger this button withProvide replacing panel kit or panel group to comprise the instruction of filter. In one embodiment,In the time that operator presses " replacing external member " button, instruction is sent to controller so that whole pumpStop and showing the screen of first shown in Fig. 9 A, it provides execution " blood backflow (BloodReturn) " the instruction of step. If there is blood coagulation in pipeline or filter, do not carry out bloodLiquid refluxes. Can skip blood backflow by " next step (the Next) " label pressing on screenStep.
At blood backflow or after skipping blood backflow step, patient and system disconnect completely,And device is prepared to carry out panel kit according to the instruction shown in Fig. 9 B and is removed. At cleaved facetAfter the connection of sleeve-board part, operator presses " next step " again, " external member unloading (KitUnload) screen command (not shown) " shows. By pressing " unloading (Unload) ",Panel kit is unloaded, makes panel folder throw off and pull on side panel in the time that pump rotates. " unloading " refers toShow that device can be repeatedly touched. The panel removing from system can be processed falls.
Do not replace panel kit in order only to replace filter, touch and " replace filter (ReplaceFilter) ". All pumps stop and the blood backflow screen of Fig. 9 A in idsplay order with guiding operationPerson before old filter and equipment disconnect through blood backflow step. Equally, ifIn pipeline or filter, have blood coagulation, blood backflow step is removed. Figure 10 A illustrates useIn patient being disconnected and removing the screen command of old filter. Because patient is necessary and systemDisconnect, therefore new filter can be ready to. In the time that old filter is disconnected, useHaemostatic clamp clamps all pipelines that are connected with filter. These pipelines sterilely disconnect,Old filter is removed, and new filter is connected, and then pipeline is released. Afterwards, operatorPress " next step " to advance to preparation (priming) step (not shown), and according toScreen step shown in Figure 10 B, reconnects system and patient. Once patient is connected,Operator presses " next step ", and treatment automatically recovers.
In order to make patient disconnect during treating, operator can touch " temporary transient disconnection evenMeet (TemporaryDisconnect) " indicator button, temporarily to disconnect and itAfter make treatment restart. Once indicator is touched, all pumps stop and occurring Fig. 9 AShown in " blood backflow " screen. As mentioned above, before patient disconnects, instructionGuiding operator is through blood backflow step. In Figure 11, illustrate that the operation of blood backflow pipeline refers toOrder. System also provides recirculation and optional flushes instructions (not shown). Optional flushing itAfter, automatically there is the screen command that patient is reconnected shown in Figure 10 B. PatientWhile reconnecting, can resume treatment.
Press to be positioned at by operator and " leave treatment (Exit on operator interface therewith touch-screenTherapy) " indicator, carries out and leaves treatment. Once this indicator is touched, all pumpsStop and occurring that the blood backflow shown in Fig. 9 A shields. Equally, if pipeline or filterIn there is blood coagulation, blood is not back to patient, and according to the step shown in Fig. 9 B,Instruction patient and equipment disconnect completely. Afterwards, by pressing " next step " indicator,Show that according to the step shown in Fig. 9 B and Figure 10 A being used for making panel kit and filter to disconnect connectsThe instruction connecing. Then system allows operator to select to leave or restart program.
Figure 12 shows " change bag (ChangeBag) " screen, can access this screen withDuring treating, change bag. If there is bag alarm or warning situation, control system is orderThe automatically activator button of bag that people is unhappy. If there is no any alarm condition, can pressThe button of bag to be replaced, or in the time that bag is removed from hook, system automatically activates and pressesButton. Once bag be replaced, fluid line is released, and if bag button on screenTouched, system is automatically reseted and is reported to the police and recover patient treatment.
Can any moment during carrying out patient treatment carry out said procedure and step. EnteringDuring row treatment, press or touch " the operation on operator interface therewith screen by operator(Operate) " button or label visit above-mentioned these procedure and steps. This label or pressButton is all presented on screen during carrying out patient treatment processing whole. By touching " operation "Label or button, screen illustrates different said procedures, comprises replacing as above bag, moreChange external member, replace filter, temporarily disconnect and leave treatment. The treatment of carrying out at present alsoCan stop at any time and start different treatments. This can touch by operator " choosingSelect shutdown or new treatment (SelectShutdownoraNewTherapy) " button (is shown in figure9A) carry out, therefore the screen of the operator interface therewith shown in Figure 13 A will appear on screen, permitPermitted operator and selected new treatment. Equally, when pressing on " next step " or screen, operator showsWhen other labels of the instruction completing steps going out, all for each follow-up pending stepScreen in succession automatically shows.
The feature of operator's control system of this equipment be also automatically and sequentially mark treat byThe different setting steps that operator carries out during system arranges. Observe Figure 13 A, in operationThe right side of person's interface screen shows different setting steps. These steps can be from top to bottom along continuousGround or one after the other carry out, and these steps comprise treatment model selection, panel kit install,Fluid pouch is installed, flow velocity is set and is connected with patient.
Start with the first pending setting steps, the choosing for the treatment of pattern has been shown in Figure 13 ASelect, operator selects required treatment by touching suitable treatment label. Select in treatmentAfterwards, the screen of Figure 13 B occurs and indicates operator to guarantee that bag hook is in place and without any pipeIn the situation of road or bag, hang, operator presses OK to proceed. Shown in Figure 13 CNext screen automatically occurs, operator inputs patient ID, body weight and hematocrit, again touchesPress OK to proceed to next step, by succession shown in Figure 13 D and Figure 13 EPending guide carrys out mounting kit. In one embodiment, panel kit and filter cartridge are establishedHave bar code, control module comprises that the panel kit that bar code scanning parts are installed to guarantee is suitableClose in choosing treatment. After according to Figure 13 D scanning panel external member, new screen (not shown)Prompting operation person treats the filter cartridge using during treating to be scanned, and presses afterwards and " sweepsRetouch (Scan) " indicator carrys out scanning bar code or manually inputs this bar code. As Figure 13 EShown in, indicate next preparation process for installing and load panel kit. Operator's handMoving ground is arranged on side panel and front panel on control module housing, and by by sensorPlug inserts in the correct socket on control module 4 pressure sensors is connected to controlUnit. Litter bag (being generally 2L bag) is connected to waste liquid pipeline. Be used for connecting various streamThe concrete pipeline of body storage bag can have colour coding. Once panel kit has been installed, operationPerson presses " load (Load) " label, control module make pump rotated to comprise by pipeline withLoading panel in pump rotor is bonded on.
The attached blood filter of the instruction of the screen for mounting kit setting steps operator shown in Figure 13 FDevice is also connected to filter by fluid circuit (pipeline). Depend on selected treatment, displacement streamBody and dialysate lines will be connected, afterwards necessary fluid storage bag, dirt pocket, displacement streamBody bag and dialyzate bag are draped. It is upper that these bags are suspended in hook (seeing Fig. 1 and 2), andAnd pipeline is attached to the bottom (see figure 3) of bag. Preferably, by suspension pollution discharge bag and pipeline is enteredEnter the top of this bag. In one embodiment, use and be to submit on October 15th, 2008The 61/105th, shown in No. 711 U.S. Provisional Patent Application (TRANSVI.027PR) and retouchThe bag hook of the good design of stating, the full content of this application is incorporated to herein by reference.
Although do not illustrate particularly, after bag is installed, screen automatically and one after the otherOccur, and for carrying out preparation system, setting flow velocity, set alarm and patient is connectedTo the task of equipment. On screen, complete flow velocity arranging shown in Figure 14 A and set, this arranges screen and existsAutomatically explict occurrence after main system setting steps completes. Operator inputs the flow velocity of hope, touchesTouch " carriage return (Enter) ", and according to the screen shown in Figure 14 B, flow velocity is confirmed. OneIn individual embodiment, can also carry out alarming limit (AlarmLimits) according to Figure 14 CConfirm or adjust. After above-mentioned steps, operator interface therewith screen automatically turn back to Figure 15 A andConnection patient shown in Figure 15 B arranges screen, and in the time that patient has connected, control modulePress " begin treatment (StartTherapy) " button during operator, enter operational mode. ?In an embodiment, that state screen as shown in Figure 15 C can be in the whole patient treatment phaseBetween show.
As previously disclosed, another feature of equipment described herein and system isCan during the current treatment of carrying out, change into different CRRT treatments, without changing panelExternal member and without change blood filter (if it is suitable in selected treatment). A realityExecute in mode, in order to change treatment during the current treatment of carrying out, operator is to fitting on screenWhen button touches, treatment that its addressable stopping (shutdown) carries out, leave treatment(exittherapy), new treatment selects maybe can allow other marks or the label (example of software restartingAs see Fig. 9 A). This program may disconnect patient during setting step as aboveConnect. But, do not need equally to change panel kit and filter.
In another embodiment, by commanding apparatus without complete setting up procedure sequence,Can carry out different treatments. For example,, if displacement liquid bag is installed with note in SCUF configurationEnter the anti-coagulants of dilution, can increase to higher appropriate speed by displacement fluid is injectedComplete the conversion from SCUF to CVVHF. The example bag of the conversion of other treatments of carrying outDraw together: by the displacement liquid flow velocity of CVVHF is adjusted into zero, complete CVVHF to SCUFOr CVVHDF is to the conversion of CVVHD; By displacement liquid bag being installed and by displacement liquidFlow velocity is adjusted into suitable treatment level, completes the conversion of CVVHD to CVVHDF. ForCarry out this conversion, control software and can be provided with operator's instruction, as device manipulation, displacement liquid bagWith pipeline installation and connection etc., these it will be appreciated by those skilled in the art that.
In one embodiment, in the time carrying out setting steps, as above in system settingSetting steps is during this time identified by different identifiers. For example, the completed step that arrangesSuddenly identified by the first identifier, current ongoing setting steps is by the second different marksSymbol identify, each still unenforced setting steps by with the first identifier and the second identifier twoPerson not identical the 3rd identifier identifies. Can summarize different setting steps by useIsolabeling does not realize this feature, for example, can carry out firmly setting to be completed of frame by solid lineStep, can by flicker or interrupted dotted line frame identify the current setting steps carrying out,By different housings or do not identify setting steps to be completed by any frame. Can replaceChange ground, setting steps identifier can have different colours, and for example, the setting steps completing hasGreen background, Set For Current step by yellow background or with the background color of the step completing notWith color illustrate, pending step is by the 3rd color or do not mark by any colorKnow, they are different from the background that the operator who shows pending task is shielded. Can use other notSame identifier is carried out this function.
It is pending and substantially in whole system that the embodiment of above-mentioned setting steps is characterised in thatStep in succession shown in system setting up procedure on operator interface therewith screen, and setting in successionStep and in response to operator, Set For Current step task is completed for the task of corresponding stepsConfirm and automatically show. In this embodiment, operator can be absorbed in screen on illustrateThe task for setting steps to be completed and that so confirm, operator need not touch settingLabel on screen or button, except confirming the completing of task illustrating on screen.
In a word, the said equipment and system allow operator to change methods for the treatment of, change panel kitAnd/or filter core, replacing bag, leave, temporarily disconnect and restart, these are all in carrying outPatient treatment during. Interactive operation person control system also provides instruction progressively with on carrying outState program. The feature of this operator's control system is also, treats the difference of being carried out by operatorSetting steps automatically and sequentially identifies and comprises: the list of pending setting steps is shown; ToCarry out, current that carrying out and still unenforced setting steps identify. Step is setRapid screen also clearly illustrate for variant setting steps and in response to operator to pendingBeing carried out by operator of the task that completes confirmation of the step illustrating on screen, automatically identifies nextSetting steps and pending continuous task. Although not shown for selecting and carrying out about figure7 and the concrete instruction of the described plasma treatment of Fig. 8, but those skilled in the art can manageSeparate, within the scope of this operation in system as described above.
Should also be understood that operator's instruction shown in figure and described herein concrete text,Order and content are only as illustrating and showing and execute, and its equipment, system and operation are not limited to this.

Claims (9)

1. substitute an equipment for patient treatment for carrying out the fluid management of selection and/or kidney,Comprise:
Control module is provided with blood pump and multiple fluid pump, described blood on described control modulePump is positioned at the blood side of described equipment and described multiple fluid pump and is positioned at the fluid of described equipmentSide; And
The panel kit that can manually replace, is arranged on described control module described panel kitComprise be provided with replaceable filter core filter core panel, the blood panel of blood supply pipeline is installedWith the fluid panel that fluid supply tube road is installed, described blood panel and described fluid panel canBe mounted to movably described filter core panel, by described filter core erecting of panel to described control moduleAfter, described blood panel be arranged at described filter core panel so that described blood supply pipeline with described inBlood pump engages, and by described filter core erecting of panel to after described control module, described fluidPanel is arranged at described filter core panel so that described fluid supply tube road engages with described fluid pump,
Wherein, described control module comprises controller and interactive operation person control system, described inController is configured to for operating described blood pump and described multiple fluid pump, described interactive behaviourAuthor's control system comprises the operator interface therewith screen being connected with described controller operability,
Wherein, described controller is established described in being configured to operate in response to operator's input selectionIt is standby,
Wherein, described interactive operation person control system is characterised in that, operator inputs,For selecting SCUF, CVVH, CVVHD, CVVHDF, plasmapheresis and treatmentProperty plasma exchange, and in current patient treatment method of carrying out for described in optionally changingPanel kit, replace described replaceable filter core and without changing panel kit and changing to notSame patient treatment method.
2. equipment as claimed in claim 1, wherein, described controller is configured to describedOperator interface therewith screen display is treated the different setting steps of being carried out by operator, and this is treated by operatorThe different setting steps of carrying out are used for changing panel kit, replace filter core and without changing panel coverPart and change to different patient treatment methods and do not change panel kit or filter core.
3. equipment as claimed in claim 2, it comprises cooperate with described control module independentFluid pouch hook and with multiple fluid storage bags of described fluid supply tube road UNICOM, wherein, instituteThe feature of the person's control system of stating interactive operation is also: be provided for carrying out the patient treatment phaseBetween change fluid keep bag setting steps.
4. substitute an equipment for patient treatment for carrying out the fluid management of selection and/or kidney,Comprise:
Control module is provided with blood pump and multiple fluid pump, described blood on described control modulePump is positioned at the blood side of described equipment and described multiple fluid pump and is positioned at the fluid of described equipmentSide, described control module comprises controller and interactive operation person control system, described controllerBe configured to for operating described blood pump and described multiple fluid pump described interactive operation person controlSystem processed comprises the operator interface therewith screen being connected with described controller operability, described controller bagDraw together the software that is configured to come in response to operator's input selection operating said equipment,
Capable replacing faceplate external member, is configured to manually be arranged on described control module and from instituteState control module and remove, described panel kit comprises filter core panel, blood panel and fluid panel,On described filter core panel, replaceable filter core is installed, on described blood panel, blood is installedSupply line and on described fluid panel, fluid supply tube road is installed, described blood panelBe mounted to movably described filter core panel with described fluid panel, described filter core panel is being pacifiedBe filled to after described control module, described blood panel is arranged at described filter core panel so that described bloodLiquid supply line engages with described blood pump, and by described filter core erecting of panel to described controlBehind unit, described fluid panel be arranged at described filter core panel so that described fluid supply tube road withDescribed fluid pump engages,
Wherein, described interactive operation person control system is characterised in that, during system arrangesAutomatically also sequentially identify pending different setting steps, comprise treatment model selection, panelExternal member is installed, fluid pouch is installed, flow velocity is set and is connected with patient.
5. equipment as claimed in claim 4, wherein, described different setting steps are by sequentiallyMark and to be displayed on described operator interface therewith screen upper, and wherein for described operator circleThe current mark setting steps illustrating on face screen, described operator's control system is described operatorInterface screen display is treated the subsequent task of being carried out by operator.
6. equipment as claimed in claim 5, wherein, described different setting steps eachCompleting steps is identified by the first identifier, and the current setting steps of carrying out is by being different fromThe second identifier of stating the first identifier identifies, still unenforced all setting steps respectively byThree identifiers different with the second identifier from described the first identifier identify.
7. equipment as claimed in claim 6, wherein, for being marked by described the second identifierThe pending subsequent task of the Set For Current step of knowing illustrates on described operator interface therewith screen,Until operator sends for the task of described Set For Current step complete to operator's control systemThe signal becoming, and in response to described signal, described operator's control system automatically shows useIn next setting steps of sequentially being identified illustrating on described operator interface therewith screen wait holdThe subsequent task of row.
8. equipment as claimed in claim 5, wherein, described operator interface therewith screen at one orPending subsequent task shown in multiple screen displays in succession, each described screen display bagDraw together touch-screen label or button that shown in mark, task completes, and wherein in response to described in touchLabel or button, next screen display in succession will automatically illustrate.
9. equipment as claimed in claim 4, wherein, described operator interface therewith screen comprise forTouch label or the button of access system operation screen, thus identifying operation person input is advancingDuring the treatment of row, optionally change panel kit, replace filter core, change fluid pouch, leaveThe new treatment of current treatment and startup.
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